Does the EPA Favor Industry When Assessing Chemical Dangers?

On a late spring morning in 2012, Michelle Boone settled into her seat on an expert panel at the U.S. Environmental Protection in Washington, D.C. As the day wore on, she felt more and more uneasy. Boone, an ecologist who works with amphibians at Miami University of Ohio, was chosen to be one of a handful of people to weigh in on the effect of a widely used pesticide on amphibians. The panel was part of the EPA’s reassessment of the rules governing the use of the controversial pesticide, called Atrazine, which has been used on billions of acres of wheat, corn and other crops since the late 1950s. It is estimated to be the most widely used weed killer in the country. The group of experts in the room that day, Boone included, had read the existing literature and had come to a unanimous conclusion, which they presented to officials: Atrazine was found in several studies to impair the reproductive development of amphibians, and should be investigated further.

But as the presentations continued, it became clear that the EPA officials had heard this all before. The agency had been at this for a while; expert panels on the same topic in 2003 and 2007 had all more or less concluded the same thing, Boone says. Yet nothing had been done; Atrazine was still marked as having no adverse effect on amphibians. It was Boone’s first time on an EPA panel, and she was shocked.

“You wonder why you’re even there, to repeat things that have already been said, and then to be ignored for reasons that are unclear,” Boone tells Newsweek.

What’s more, the EPA had disqualified from rule-making consideration all but one study on the effect of Atrazine on amphibians. The lone remaining study was funded by Syngenta, the company that manufactures Atrazine. Most other papers on Atrazine had found some connection between the chemical and adverse effects on amphibians. The Syngenta-funded study showed none.

“[Scientists] always want more data. So when you’re sitting on a panel, you’ve read enough literature to know that there are a lot of studies that have found some effect that should probably at least be investigated,” she says. “And then there’s only one study! And it is an industry-funded study. That was shocking to me.”

The EPA did not immediately respond to a request for comment on the topic covered by the report.

Most of the rejected studies were authored by Tyrone Hayes, a biologist at the University of California Berkeley whose work on Atrazine and controversial struggle with Syngenta was documented in a New Yorker feature earlier this year. Hayes continues to allege that he is the victim of a smear campaign perpetrated by Syngenta to devalue his findings, which suggest Atrazine can cause sexual abnormalities in frogs at concentrations 30 times less than what the EPA allows in water.

The EPA disqualified Hayes’s studies because they failed to meet the agency’s methodological criteria. While Boone concedes that some of Hayes’s studies “weren’t perfect,” she emphasizes that the criteria the EPA applied wound up disqualifying the studies on potentially irrelevant grounds. “They were throwing a lot of things out that didn’t prevent you from making a cause-and-effect analysis,” she says. For example, any study that raised its test amphibians in plastic containers, instead of glass, failed to meet EPA criteria. But, Boone notes, that’s why experiments always have controls—to eliminate any interference caused by things like lab materials.

“Plastic can leach estrogenic compounds, which is potentially of concern. But you still have controls. If you have control animals raised in plastic that don’t show these estrogenic effects, and then the ones who are exposed to Atrazine do [show affects],” that’s a valid cause-and-effect observation that can be pinned to Atrazine, Boone says, and it should be taken into account.

Syngenta’s financial interest in maintaining the chemical’s status as safe for amphibians seemed to Boone to be an obvious conflict of interest. After the paperwork she and her colleagues were required to file certifying that they presented no conflicts of interest by serving on the panel, this seemed patently bizarre.

“They know what a conflict of interest is, because they’re asking us to fill out forms asking if we have financial investments that could influence your decision, or give the appearance that it could,” Boone says. “They’re aware of them, but then the whole regulatory system is built upon the idea that the manufacturer is responsible to find out if their product presents a hazard.”

Under the Toxic Substances Control Act of 1976, the EPA has 90 days to review any new chemical, and determine regulatory guidelines like safe levels of use. If the EPA does not set regulations within that time—and they often don’t—companies are free to use and sell that chemical how they see fit.

EPA has only tested and published data on approximately 200 of the 83,000 chemicals in its inventory, according to a California Senate review from 2010. Concerns over health effects can lead the EPA to take a second look at certain chemicals, as is the case with Atrazine.

It was Boone’s first time on an EPA panel, and she was shocked by the process. Officials and more veteran panelists, however, seemed unruffled. It appeared to be business as usual. “They were all functioning like this didn’t seem weird to them,” she says.

Boone’s experience was enough to prompt her to gather ecotoxicology colleagues and pen a report on the EPA’s regulatory process for chemicals—and not just Atrazine. The report, published Wednesday, is an interrogation of what the authors call the many “clear conflicts of interest” permitted in the EPA’s rule-making process.

For example, the EPA “works with industry to establish the methodology and experimental design for studies,” because “complexity and logistics of these designs can make them prohibitively expensive for researchers outside of industry, often leaving industry as the only entity that can afford to conduct the research to the USEPA’s specifications or that is knowledgeable of the requirements. Therefore, all or most of the data used in risk assessments may come from industry-supplied research, despite clear [conflicts of interest],” the paper reads.

In a formal review of the case of Atrazine’s reassessment, the authors found that “the best predictor of whether the herbicide Atrazine had significant biological effects in a study was the funding source.” If the study was funded by Syngenta, it had “a greater likelihood of finding no effect or only small effects” caused by the chemical. The same holds true for industry-funded studies of the controversial plastic additive bisphenol A, as well as studies of various pharmaceutical products, according to the paper.

The EPA’s final conclusion on what levels of Atrazine can be considered “safe” are not due until 2016. In the meantime, Boone hopes that the agency will take a “weight-of-evidence” approach to Atrazine, and include the warnings embedded in many of the other studies they initially rejected.

“It isn’t that I think Atrazine should definitely be banned or used. That’s beyond the data; people have to evaluate a lot of different things, like socioeconomic impact. But there are a lot of studies that suggest Atrazine can affect reproductive endpoints, and we need to figure that out,” Boone says. “They’re not asking those questions.”